Fasciitis, Plantar Clinical Trial
Official title:
Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain: A Randomized Clinical Trial
NCT number | NCT01865734 |
Other study ID # | 04-13-02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2013 |
Est. completion date | November 2017 |
Verified date | January 2019 |
Source | Des Moines University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical therapy practice and often is associated with chronic symptoms, and disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of care for PHP. Two practice guidelines are available to direct management patterns, but the guidelines and recent evidence of PHP interventions are unclear about the timing and influence of physical therapy in the multidisciplinary management of PHP. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP. It is hypothesized that there will be greater improvement and/or reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment provided in the uPOD group will reflect usual management patterns and intervention will be determined by the podiatrist. Treatment provided in the ePT group will be determined by the physical therapist and will focus on impairment-based manual therapy and exercise to the lower half of the body. In addition, evidence-based pain modulating modalities will be integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle Ability measure (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale (NPRS), Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The association between successful outcome based on GROC score and patient expectation of physical therapy or podiatry, and general expectations of symptom improvement will be analyzed. The results of this investigation will help to determine the impact of ePT to inform practice, update existing guidelines to reduce practice variation, and identify the most cost effective treatment for patients with PHP.
Status | Completed |
Enrollment | 95 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of Plantar Heel Pain: Tenderness to palpation of the plantar heel, pain associated with first step after waking, or pain with progression of daily weightbearing - Patient's primary complaint is plantar heel pain Exclusion Criteria: - Score less than 74/84 on the Foot and Ankle Ability Measure activities of daily living (ADL) subscale - Unable to complete questionnaires - No treatment for heel pain in last 6 weeks - Duration of symptoms greater than 1 year - Current fracture of the lower leg, ankle, or foot - Neurological condition affecting function of lower leg - Advanced peripheral artery disease - Rheumatoid arthritis - Osteoporosis - Active cancer - Prolonged steroid use - Surgery of the lower leg, ankle, or foot |
Country | Name | City | State |
---|---|---|---|
United States | Des Moines University | Des Moines | Iowa |
Lead Sponsor | Collaborator |
---|---|
Des Moines University | American Physical Therapy Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Foot and Ankle Ability Measure | 6 months | ||
Secondary | Numeric Pain Rating Scale | The average of the least, current, and worst pain in the last week will be used. | Baseline, 6 weeks, 6 months, 1 year | |
Secondary | Global Rating of Change Scale | 6 weeks, 6 months, 1 year | ||
Secondary | Incremental cost-effectiveness ratio | Incremental cost-effectiveness ratio will be calculated per quality-adjusted life year (QALY) gained determined by response on the European Quality of Life - 5 Dimensions | 6 weeks, 6 months, 1 year | |
Secondary | Foot and Ankle Ability Measure | Baseline, 6 weeks, and 1 year |
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